Efficacy of Antimicrobial Prophylaxis for Shock Wave Lithotripsy (SWL) on Reducing Urinary Tract Infection (UTI)

Lawson Health Research Institute

Status and phase

Terminated

Phase 3

Conditions

Urolithiasis

Treatments

Drug: Ciprofloxacin

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01873690

103696

Details and patient eligibility

About

The purpose of this research study is to test whether administering one dose of an antibiotic before a routine shock wave lithotripsy procedure is more effective at avoiding any urinary infections compared to not taking an antibiotic. This is an important topic to study because urinary tract infections are one of the most common complications after this procedure and there is no clear standard of care regarding the use of pre-procedure antibiotics. Our study results will benefit future patients either by decreasing the rate of infections or decreasing the use of unnecessary antibiotics.

Enrollment

360 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Scheduled for SWL at St. Joseph's Hospital;
18 years of age or older;
Willing and able to complete Questionnaires;
Willing to submit urine sample for analysis at Day 7;
Able to read and speak English.

Exclusion criteria

Pre-SWL urine analysis positive for nitrites or urine culture reveals >105 CFU/ml of bacteria (positive urine culture);
Taking antibiotics for UTI or other cause;
Requires an antibiotic post SWL;
Suspected struvite stone (based on previous stone analysis, or partial staghorn);
Presence of nephrostomy tube;
Requiring cystoscopy on the day of SWL;
Requiring ureteral stent on the day of SWL;
Presence of indwelling urinary catheter or on regular clean intermittent catheterization (CIC);
Presence of urinary diversion (ie: ileal conduit);
Any history of urosepsis;
Known allergic reaction to ciprofloxacin/quinolones;
Patient known to be pregnant;
Previous randomization in this trial;
In the opinion of the urologist, it is not in the patient's best interest to participate.